CHLORHEXIDINE DIGLUCONATE 20 % w/v SOLUTION
1,1’-hexamethylenebis[5-(p-chlorophenyl) biguanide] digluconate 1,6-bis(N´-p-chlorophenyl-N5-biguanido)hexane digluconate
C22 H30 Cl2 N10 . 2C6 H12 O7
1000 Kg IBC Containers. 50 Kg and 200 Kg HDPE drums.
Classified as hazardous substance according to transport regulations (class 9, UN 3082)
SPECIFICATIONS AT RELEASE (EP)
|Description||Almost colourless or pale-yellowish liquid|
|Identification Test A||The IR spectrum complies with Chlorhexidine CRS spectrum|
|Identification Test B||The principal spot in the chromatogram obtained with the test solution is similar in position, colour and size to the principal spot in the chromatogram obtained with the reference solution|
|pH||5.5 to 7.0|
|Related Substances||Impurity A: NMT 0.4%
Impurity B: NMT 0.2%
Impurity F: NMT 0.2%
Impurity G: NMT 0.3%
Impurity H: NMT 0.5%
Impurities I + O: NMT 0.4%
Impurity J: NMT 0.4%
Impurity K: NMT 0.4%
Impurity L: NMT 0.2%
Impurity N: NMT 1.0%
Impurity Q: NMT 0.2%
Any unspecified impurity: NMT 0.10%
Total impurities: NMT 3.0%
|Impurity P (chloroaniline)||Not more than 500 ppm (regularly NMT 10 ppm at release)|
|Assay||19.0 to 21.0 % (w/v)|
BIOCIDAL PRODUCTS DIRECTIVE (BPD) – DIRECTIVE 98/8/EC
- In 2007 Medichem, S.A. notified Chlorhexidine Digluconate (CAS No. 18472-51-0, EC No. 242-354-0) according to BPD for its use as an active substance in the following product types:
PT1: human hygiene biocidal products
PT2: private area and public health area disinfectants and other biocidal products
PT3: veterinary hygiene biocidal products
- This dossier is under evaluation by the Representative member state (Portugal). Once the dossier is approved, Chlorhexidine Digluconate will be included in Annex I of the BPD.Meanwhile, we provide our clients any assistance required for their national submissions. In october 2013, ECHA published the list of active substance suppliers, the provisional list which will form the basis of the list ECHA will publish under art 95 of the BPR (Biocidal Products Regulation, 528/2012). Chlorhexidine Digluconate, manufactured by Medichem, S.A. has been included in the list.
- According to the BPR, from 1st September 2015, a biocidal product cannot be placed on the EU market if the manufacturer or importer of the active substance contained in the biocidal product, or where relevant, the importer of the biocidal product, is not included in the art 95 list.
Medichem has also registered Chlorhexidine Digluconate in 2013 according to the requirements and timeframes of REACH regulation.
Registration number: 01-2119946568-22-0001.
Medichem performs ongoing stability studies on Chlorhexidine Digluconate to ensure continuous quality throughout their retest period. Retest period can only be guaranteed if the product is stored as indicated below.
- Store preferably below 25º C. Do not allow the product to freeze. If this happens, it can be rehomogeneized maintaining the same properties.
- Keep in the original drums tightly closed.
- Keep the drums away from direct sunlight.